Ohlbe
★★★

France,
2015-10-11 13:35
(3091 d 01:17 ago)

Posting: # 15549
Views: 6,091
 

 BMV: Health Canada clarification on stabs [Bioanalytics]

Dear all,

Health Canada have published a clarification on the stability experiments in matrix. Basically: the results should be generated from independent aliquots, not from replicate measurements of a single aliquot.

Regards
Ohlbe
ElMaestro
★★★

Denmark,
2015-10-12 00:08
(3090 d 14:45 ago)

@ Ohlbe
Posting: # 15552
Views: 5,153
 

 BMV: Health Canada clarification on stabs

Hi Ohlbe,

thanks.
Am I right in thinking the implication is that n indepently prepared spiking (parent) solutions need to be produced if we want n replicates of the experiment?

Pass or fail!
ElMaestro
Ohlbe
★★★

France,
2015-10-12 00:34
(3090 d 14:19 ago)

@ ElMaestro
Posting: # 15553
Views: 5,157
 

 BMV: Health Canada clarification on stabs

Dear ElMaestro,

❝ Am I right in thinking the implication is that n indepently prepared spiking (parent) solutions need to be produced if we want n replicates of the experiment?


I would say no. They say that
[...] it provides limited (i.e., N = 1) information regarding the effects of the storage conditions on accuracy and no information on the effects of the conditions on the variability of the drug concentration.

Having n preparations from n spiking solutions would only add the variability of the preparation, not information on the effects of the storage condition.

They also later say regarding insufficient data that
In these cases, an amendment to the validation report will be requested that includes stability experiments conducted using sets of low and high QC samples aliquoted prior to the stability experiment and all samples subjected to the given stability conditions independently prior to processing.

My understanding is 1 aliquot from each of n tubes from the same bulk spiking (but not n aliquots taken from a single tube after thawing the stability sample).

Regards
Ohlbe
nobody
nothing

2015-10-13 13:56
(3089 d 00:56 ago)

@ Ohlbe
Posting: # 15554
Views: 5,041
 

 BMV: Health Canada clarification on stabs

@Ohlbe, makes perfectly sense to me, to store the samples in separate aliquots (as the clinical samples), but prepared from one stock sample (simple spike), so no additional source of variation is added.

Kindest regards, nobody
Helmut
★★★
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Homepage
Vienna, Austria,
2015-10-13 17:18
(3088 d 21:34 ago)

@ nobody
Posting: # 15555
Views: 5,026
 

 BMV: Health Canada clarification on stabs

Hi nobody,

❝ @Ohlbe, makes perfectly sense to me, to store the samples in separate aliquots (as the clinical samples), but prepared from one stock sample (simple spike), so no additional source of variation is added.


Exactly. To name some good reasons:
  • Ratio of volume to (sometimes adsorptive!) surface.
  • Stoppers!
  • Thawing of a bulk sample is difficult and different from clinical samples.
It is beyond me why someone would get this idea in the first place. Never seen that.

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